The manuscript was written by two academic authors and four industry authors. ); University Medical Center Ljubljana, Ljubljana, Slovenia (J.T. Results were similar for the subgroup of white patients (For immunologically confirmed hypersensitivity reaction, the HLA-B*5701 allele was associated with a positive predictive value of 47.9% and a negative predictive value of 100%. Phillips and Hay, receiving consulting fees, lecture fees, and other payments from GlaxoSmithKline; Drs. HLA-B*5701–positive patients in the prospective-screening group did not receive abacavir as part of the study (HLA-B*5701 screening was performed with the use of DNA-sequence–based typing (at the Centre for Clinical Immunology and Biomedical Statistics, Royal Perth Hospital, Perth, Western Australia) and a sequence-specific oligonucleotide probe method (Laboratory Corporation of America), with additional DNA sequencing for patients for whom the probe results were positive. All the authors evaluated the study results, reviewed and edited the manuscript, and vouch for the completeness and accuracy of the data presented.Patients were assessed for eligibility and were randomly assigned to undergo either prospective or retrospective HLA-B*5701 testing between April and September 2006 at 265 centers in 19 countries.
In some cases, additional time should be However, only those from patients who had been randomly assigned to the prospective-screening group were subjected to real-time testing for carriage of HLA-B*5701 during the evaluation period. Koopmans, G.J.
The safety population for analyses of adverse events and laboratory data included all patients who received at least one dose of abacavir.The rates of clinically diagnosed hypersensitivity reaction were compared between the two groups by means of logistic-regression analysis, with the P value calculated with the use of the likelihood-ratio test.
Mayo Clinic does not endorse any of the third party products and services advertised.A single copy of these materials may be reprinted for noncommercial personal use only. This study was designed to establish the effectiveness of prospective HLA-B*5701 screening to prevent the hypersensitivity reaction to abacavir.This double-blind, prospective, randomized study involved 1956 patients from 19 countries, who were infected with human immunodeficiency virus type 1 and who had not previously received abacavir.
The only events of grade 2, 3, or 4, reported in more than 1% of the study population, were drug hypersensitivity (in 79 of 1772 patients [4.5%]) and diarrhea (in 32 of 1772 patients [1.8%]). Maintain blood specimen at room temperature.
allowed for additional confirmatory or additional reflex tests. HLA-B5701. Sample Requirements: Anticoagulated Blood ACD (yellow top, solution A or B) Requested Volume: One 7-10 ml ACD (yellow top) tube: …
D'Arminio Monforte, C. Daniel, A. ); AIDS Research Initiative, Darlinghurst, Australia (C.W. However, the double-blind design also means that we could not address the potential benefits of HLA-B*5701 screening observed in open-screening studies in the clinic, such as a decrease in the rate of false positive clinical diagnoses of hypersensitivity reaction in patients known to be HLA-B*5701–negative.The 3.4% rate of clinically diagnosed hypersensitivity reaction that was not immunologically confirmed in the prospective-screening group is similar to the false positive rates of hypersensitivity reaction (2 to 7%) among patients not receiving abacavir in double-blind comparative-treatment studies.Although a positive result of epicutaneous patch testing in our study indicates a true, immunologically mediated hypersensitivity reaction to abacavir, a negative result can neither rule out this diagnosis nor be used to justify rechallenge with abacavir. Profile or Test Panel: Testing for Individual HLA alleles: Indications: Determination of the presence or absence of HLA B*5701: Method: Molecular: Test Information : Molecular typing methods used to determine the presence or absence of the HLA B*5701 allele. In predominantly white populations, similar to the one in this study, 94% of patients do not carry the HLA-B*5701 allele and are at low risk for hypersensitivity reaction to abacavir. To test for the HLA-B*5701allele, a blood or saliva specimen is collected.
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